INTERVENTIONAL PLATFORM STUDY INVESTIGATING THE IMPACT OF DIGITAL HEALTH SOLUTIONS ON HEALTH OUTCOMES AND HEALTH-CARE RESOURCE UTILIZATION IN PARTICIPANTS RECEIVING SYSTEMIC TREATMENT IN CLINICAL PRACTICE (ORIGAMA)

Conditions

8th edition) non-small cell lung carcinoma (NSCLC), Cohort A: • Metastatic non-small cell lung carcinoma (mNSCLC) • Extensive-stage small-cell lung carcinoma (ES-SCLC) • Advanced or unresectable hepatocellular carcinoma (HCC) Cohort B: • Resected Stage IIB-IIIB (early-stage; per the UICC/AJCC staging system

Brief summary

1. Mean difference in change of Week 12 value from baseline of the participant-reported Total Symptom Interference Score from the MD Anderson Symptom Inventory (MDASI) Core Items, 2. At-home treatment adoption at Cycle 6

Detailed description

1. Number of hospitalizations and number of cumulative days hospitalized due to serious adverse events (SAEs), 2. Unscheduled visits to the emergency room (ER) or clinic visits for symptom management, 3. Incidence, nature, and severity of all anti-cancer treatment associated adverse event (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 with additional analyses on Grade >= 3 AEs, Serious adverse events (SAEs), selected immune-related adverse events, weighted toxicity score (WTS), interruption, modification, or discontinuation of atezolizumab regimen due to AEs, 4. Change from baseline in Global Health Status score/Quality of Life score (GHS/QoL) from the European Organisation for Research and Treatment of Cancer (EORTC) item library 6 (IL6) GHS/QoL, 5. Change from baseline in EuroQoL 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) index-based and visual analogue Scale (VAS) instrument, 6. Change from baseline in the mean symptom severity score from the MDASI Core Items, 7. Incidence and severity of adverse events assessed as related to device use and adverse device effects, 8. Incidence, nature, and severity of anti-cancer treatment associated AEs as described in the secondary efficacy objectives, 9. Incidence, nature, and severity of all Atezolizumab SC associated AEs graded according to the NCI-CTCAE v5.0 with additional analyses on: - Grade ≥ 3 AEs - SAEs

Related papers

No related papers found yet.

Interventions

DRUGRO5541267

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Mean difference in change of Week 12 value from baseline of the participant-reported Total Symptom Interference Score from the MD Anderson Symptom Inventory (MDASI) Core Items, 2. At-home treatment adoption at Cycle 6	—

Secondary

Measure	Time frame
1. Number of hospitalizations and number of cumulative days hospitalized due to serious adverse events (SAEs), 2. Unscheduled visits to the emergency room (ER) or clinic visits for symptom management, 3. Incidence, nature, and severity of all anti-cancer treatment associated adverse event (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 with additional analyses on Grade >= 3 AEs, Serious adverse events (SAEs), selected immune-related adverse events, weighted toxicity score (WTS), interruption, modification, or discontinuation of atezolizumab regimen due to AEs, 4. Change from baseline in Global Health Status score/Quality of Life score (GHS/QoL) from the European Organisation for Research and Treatment of Cancer (EORTC) item library 6 (IL6) GHS/QoL, 5. Change from baseline in EuroQoL 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) index-based and visual analogue Scale (VAS) instrument, 6. Change from baseline in the m	—

Measure

Time frame

1. Number of hospitalizations and number of cumulative days hospitalized due to serious adverse events (SAEs), 2. Unscheduled visits to the emergency room (ER) or clinic visits for symptom management, 3. Incidence, nature, and severity of all anti-cancer treatment associated adverse event (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 with additional analyses on Grade >= 3 AEs, Serious adverse events (SAEs), selected immune-related adverse events, weighted toxicity score (WTS), interruption, modification, or discontinuation of atezolizumab regimen due to AEs, 4. Change from baseline in Global Health Status score/Quality of Life score (GHS/QoL) from the European Organisation for Research and Treatment of Cancer (EORTC) item library 6 (IL6) GHS/QoL, 5. Change from baseline in EuroQoL 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) index-based and visual analogue Scale (VAS) instrument, 6. Change from baseline in the m

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Countries

Austria, Germany, Spain

Outcome results

None listed